title: Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial.
abstract: BACKGROUND
  Chronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS.
  
  
  METHODS
  The SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management ('SQS arm') versus optimized medical management alone ('OMM arm') in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline.
  
  
  CONCLUSIONS
  The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01711619.
authors.affiliation: The James Cook Hospital, Middlesbrough, UK.
authors.forename: Sam
authors.initials: S
authors.lastname: Eldabe
authors.forename: Michael
authors.initials: M
authors.lastname: Kern
authors.forename: Wilco
authors.initials: W
authors.lastname: Peul
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.forename: Kristi
authors.initials: K
authors.lastname: Winterfeldt
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
mesh_terms: D000700:Analgesics / Q000627:therapeutic use; D001315:Australia; D001416:Back Pain / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005060:Europe; D017048:Health Care Costs; D006801:Humans; D019637:Orthopedic Procedures / Q000009:adverse effects* / Q000191:economics; D010147:Pain Measurement; D010148:Intractable Pain / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D010149:Postoperative Pain / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D017060:Patient Satisfaction; D011237:Predictive Value of Tests; D011788:Quality of Life; D012107:Research Design; D013131:Spine / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects / Q000191:economics*; D017211:Treatment Failure
chemical_list: D000700:Analgesics